Inhaled DMT for Major Depressive Disorder

This Phase 2b, randomized, double-blind, active-controlled clinical trial will evaluate the efficacy and safety of inhaled N,N-dimethyltryptamine (DMT) in adults with Major Depressive Disorder (MDD). The study will test whether inhaled DMT can rapidly reduce depressive symptoms and suicide risk compared with a low-dose active comparator. A total of 140 participants will be randomized 1:1 to receive either 15 mg followed 1 hour later by 60 mg of inhaled DMT, or 1 mg followed 1 hour later by 4 mg of inhaled DMT. Participants who do not achieve remission at Day 7 will enter an open-label extension and receive a high-dose DMT session on Day 14 (±3 days). All participants will be followed for up to 12 months to evaluate the durability of response, safety, functioning, and quality of life.

NCT Number	NCT07562191
Lead Sponsor	Universidade Federal do Rio Grande do Norte Collaborators: Financiadora de Estudos e Projetos
Conditions	MDD, Major Depressive Disorder (MDD), Major Depression, Suicidal Ideation, Suicide
Enrollment	140 participants
Start Date	2026-08-01
Primary Completion	2027-02-01 (estimated)
Study Completion	2027-08-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-13